Model Number 4FC12 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, the sheath was unable to aspirate without air bubbles after the balloon catheter was inserted.The sheath was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Visual inspection of the sheath showed that the device was intact with no apparent issues.Flushing/air aspiration testing did not show any air passing through the tube or expelled from the distal tip.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.A torn valve disk was suspected.Also, the sheath was kinked 3 inches from the tip and there was shaft kink.In conclusion, the reported air ingress issue during aspiration was confirmed through testing.The sheath failed the returned product inspection due to a leaking hemostatic valve and shaft kink.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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